Lemtrada Side Effects

Generic name: alemtuzumab

Medically reviewed by Drugs.com. Last updated on Dec 14, 2024.

Note: This document provides detailed information about Lemtrada Side Effects associated with alemtuzumab. Some dosage forms listed on this page may not apply specifically to the brand name Lemtrada.

Applies to alemtuzumab: intravenous solution.

Precautions

It is very important that your doctor check your progress closely and at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects during treatment and for 48 months after your last dose. If you have signs or symptoms of an autoimmune disease, your doctor may continue to check your progress after 48 months. It is also important that your doctor check your skin for melanoma (tumor) yearly. Be sure to keep all appointments.

Do not use this medicine if you are also receiving or have received Campath®.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent from getting pregnant while you are receiving this medicine and for at least 4 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause serious infusion reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a cough, difficulty with swallowing, dizziness, fast heartbeat, trouble breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving this medicine.

This medicine may increase your risk of having a stroke (eg, ischemic and hemorrhagic stroke) and tears in your arteries that supply blood to your brain (carotid and vertebral arteries). Check with your doctor right away if you have parts of your face that are drooping, weakness on one side of your body, sudden, severe headache, difficulty with speech, or neck pain.

This medicine may increase your risk of cancer, including thyroid, skin, or lymph node cancer. Call your doctor right away if you have a new lump or swelling in the neck, cough, hoarseness or voice changes, neck pain, or trouble with breathing or swallowing.

This medicine may cause autoimmune disorders, including immune thrombocytopenia (ITP), hepatitis (swelling of the liver), or encephalitis (swelling of the brain). Tell your doctor right away if you have confusion, irritability, headache, seizures, stiff neck, unusual nausea, vomiting, stomach pain, tiredness, loss of appetite, or yellow eyes or skin, dark urine, a bloody nose, coughing or spitting up blood, small red or purple spots on skin, or heavier than normal or irregular monthly periods.

This medicine may cause a serious kidney problem called anti-glomerular basement membrane disease. Call your doctor right away if you have blood in the urine, coughing up blood, or swelling in your legs or feet.

Alemtuzumab may cause hemophagocytic lymphohistiocytosis, a severe inflammatory condition which can be life-threatening, which is caused by an overactive immune system. The symptoms of this disease may occur within 13 to 33 months after starting treatment with this medicine. Check with your doctor right away if you have a fever, right upper abdominal or stomach pain and fullness, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, mental status changes, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, or seizures.

This medicine may cause Adult onset Still's disease (AOSD), a rare inflammatory condition which can be life-threatening. Call your doctor right away if you have a high fever lasting more than 1 week, pain, stiffness with or without swelling in multiple joints, or skin rash.

This medicine may cause thrombotic thrombocytopenic purpura, which can be life-threatening. Check with your doctor right away if you have black, tarry stools, blood in the urine, bloody nose, fever, heavier menstrual periods, pinpoint red spots on the skin, skin rash, unusual bleeding or bruising or unusual tiredness or weakness.

This medicine may increase your risk for serious bleeding problems, including acquired hemophilia A. Check with your doctor right away if you have nosebleeds, blood in the urine or stools, or any unusual bleeding or bruising.

While you are being treated with alemtuzumab (the active ingredient contained in Lemtrada) and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. You should receive live vaccines for at least 6 weeks before starting treatment with this medicine. You should not also receive alemtuzumab until 6 weeks after a varicella zoster virus (chicken pox) vaccination. Alemtuzumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Alemtuzumab can temporarily lower the number of white blood cells in your blood, which will increase the risk of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, these are precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are receiving this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start receiving this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Tell your doctor right away if you have been exposed to someone with chickenpox.

If you are a female, you should have a human papilloma virus (HPV) screening every year to avoid getting a cervical HPV infection.

You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.

Do not eat foods that may contain a bacteria called Listeria, such as deli meat, unpasteurized milk and cheese products, or not properly cooked meat, seafood, or chicken. Make sure that the food you eat which may contain listeria is heated well when you receive this medicine.

Tell your doctor right away if you have unexplained weight gain or loss, constipation, fast, pounding, or uneven heartbeat, feeling cold, swelling of the eye. These may be symptoms of a thyroid problem.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor if you have weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes.

This medicine can increase your risk of having gallbladder (eg, acalculous cholecystitis) and lung problems (eg, pneumonitis). Check with your doctor right away if you have stomach pain or tenderness, fever, nausea, vomiting, trouble breathing, cough, chest pain or tightness, or coughing up blood.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Lemtrada

Along with its needed effects, alemtuzumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking alemtuzumab:

Other side effects of Lemtrada

Some side effects of alemtuzumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to alemtuzumab: intravenous solution.

Hematologic adverse events

• Very common (10% or more): Lymphopenia (97%), neutropenia (77%), anemia (76%), thrombocytopenia (71%), granulocytopenia
• Common (1% to 10%): Decrease in CD4 lymphocytes, decrease in CD8 lymphocytes, decrease in T-lymphocyte count, febrile neutropenia, pancytopenia, leukopenia, lymphopenia, purpura
• Uncommon (0.1% to 1%): Aplasia bone marrow, disseminated intravascular coagulation, hemolytic anemia, decreased haptoglobin, bone marrow depression, hematology test abnormal^[Ref]

Immunologic

• Very common (10% or more): Immunogenicity (up to 83%), herpes viral infection (16%), fungal infection (13%), sepsis, cytomegalovirus infection, cytomegalovirus
• Common (1% to 10%): Influenza, neutropenic fever
• Uncommon (0.1% to 1%): Sepsis, staphylococcal bacteremia, tuberculosis, beta hemolytic streptococcal infections, candidiasis, genital candidiasis, body tinea
• Very rare (less than 0.01%): Immune thrombocytopenia
• Frequency not reported: Autoimmunity^[Ref]

viremia

Respiratory

• Very common (10% or more): Nasopharyngitis (25%), upper respiratory tract infection (16%), sinusitis (11%), pneumonia
• Common (1% to 10%): Cough, dyspnea, bronchitis, chest discomfort, epistaxis, hypoxia, hemoptysis, bronchospasm
• Uncommon (0.1% to 1%): Stridor, throat tightness, pulmonary infiltration, pleural effusion, breath sounds decreased, respiratory disorder
• Frequency not reported: Respiratory alkalosis^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (21%), diarrhea (12%), oropharyngeal pain (11%), abdominal pain (10%), vomiting (10%)
• Common (1% to 10%): Dyspepsia, gastrointestinal hemorrhage, ulcerative stomatitis, stomatitis, gastroenteritis, tongue ulceration, gingivitis, hiccup, eructation, dyspepsia, constipation, flatulence, oral candidiasis
• Uncommon (0.1% to 1%): Gingival bleeding, dry mouth, paralytic ileus, oral discomfort
• Frequency not reported: Duodenal ulcer, intestinal perforation, melena, peptic ulcer, pseudomembranous colitis, colitis, pancreatitis, peritonitis^[Ref]

Nervous system

• Very common (10% or more): Headache (52%), insomnia (16%), paresthesia (10%), dizziness (10%)
• Common (1% to 10%): Dysgeusia, vertigo, tremor, paresthesia, hypoesthesia, hyperkinesia, taste loss
• Uncommon (0.1% to 1%): Syncope, abnormal gait, dystonia, hyperesthesia, neuropathy, taste perversion^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension, hypertension
• Common (1% to 10%): Tachycardia, peripheral edema, vasospasm
• Uncommon (0.1% to 1%): Cardiac arrest, myocardial infarction, atrial fibrillation, supraventricular tachycardia, arrhythmia, bradycardia, abnormal ECG, peripheral ischemia, cyanosis, orthostatic hypotension, hot flush
• Frequency not reported: Congestive heart failure, cardiomyopathy, decreased ejection fraction in non-MS patients previously treated with potentially cardiotoxic agents^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (12%), pain in extremity (12%), back pain (12%)
• Common (1% to 10%): Chills, muscular weakness, muscle spasms, myalgia, neck pain, arthralgia, skeletal pain, back pain
• Uncommon (0.1% to 1%): Leg pain, hypertonia, muscle spasms
• Frequency not reported: Arthritis or worsening arthritis, bone fracture, myositis, muscle atrophy, osteomyelitis, polymyositis, skeletal pain^[Ref]

Dermatologic

• Very common (10% or more): Rash (53%), urticaria (16%), pruritus (14%)
• Common (1% to 10%): Dermatitis, erythema, hyperhidrosis, bullous eruption, erythematous rash
• Uncommon (0.1% to 1%): Maculopapular rash, skin disorder^[Ref]

Endocrine

• Very common (10% or more): Thyroid gland disorders (13%)^[Ref]

Hepatic

• Frequency not reported: Hyperbilirubinemia, hepatic failure, hepatocellular damage, hypoalbuminemia, biliary pain^[Ref]

Metabolic

• Very common (10% or more): Anorexia
• Common (1% to 10%): hyponatremia, hypocalcemia, weight decrease, dehydration, thirst
• Uncommon (0.1% to 1%): Hypokalemia, diabetes mellitus aggravated
• Frequency not reported: Thyroid disorder, fluid overload^[Ref]

Oncologic

• Frequency not reported: Malignancies (e.g., malignant lymphoma, malignant testicular neoplasm, prostatic cancer, plasma cell dyscrasias, secondary leukemia, squamous cell carcinoma)^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (19%)
• Common (1% to 10%): Blood in urine, abnormal uterine bleeding
• Uncommon (0.1% to 1%): Impotence, urinary incontinence, urine flow decreased, polyuria, cystitis
• Frequency not reported: Cervical dysplasia^[Ref]

Other

• Very common (10% or more): Pyrexia (29%), fatigue (18%), flushing (10%)
• Common (1% to 10%): Asthenia^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal function abnormal
• Frequency not reported: Acute renal failure^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Uncommon (0.1% to 1%): Endophthalmitis^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Allergic reaction
• Frequency not reported: Anaphylactoid reaction^[Ref]

Local

• Uncommon (0.1% to 1%): Infusion site bruising, infusion site dermatitis, infusion site pain
• Frequency not reported: Infusion reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia (including atrial fibrillation), hypoxia, syncope, acute respiratory distress syndrome, respiratory arrest, myocardial infarction, acute cardiac insufficiency, cardiac arrest, transient neurologic symptoms, hypertension, headache, pyrexia, rash, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnea, pulmonary infiltrates, dysgeusia, dyspepsia, dizziness, pain)^[Ref]

See also:

Frequently asked questions

• What are the new drugs used for multiple sclerosis (MS)?

Further information

Lemtrada side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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